Biosafety and Single Use (SU) Bioprocess Technology · What is Single Use Bioprocess Technology? • Replaces the ‘stainless steel’ equipment: – Bioreactors – Process tanks

Biosafety andSingle Use (SU) Bioprocess 

TechnologyBrian R. Petuch RBP, CBSP

Merck and Co.

What is Single UseBioprocess Technology?

• Replaces the ‘stainless steel’ equipment:– Bioreactors– Process tanks– Filtration systems– Centrifuges

• Replaces ‘hard pipe’ sanitary connections with flexible heat‐welded tubing connections.

Examples

Shukla and Gottschalk, Trends in Biotech, 2013

Processes Benefitingfrom SU Technology

• Vaccines– Attenuated – Inactivated– Toxoids– rDNA‐based

• Monoclonal antibodies• Therapeutic Proteins• Gene therapy vectors

SU Advantages

• Reduction of inter‐batch cleaning time and labor

• Reduction in cleaning validation requirements• Reduction of utility requirements

– Steam– Cooling water

• Reduced facility infrastructure

SU Biosafety Concerns• Increased infectious solid waste processing• Leaks

– Fluid connections– Process probes

• Overpressure– Process control– Vent filter binding

SU Biosafety Concerns• Risk of total vessel failure

– Aerosol release– Spill response

• Inactivation of liquid wastes

Risk Mitigation

• Rigorous process safety control studies (HAZOPS, What‐If).

• Design of skid containment options• Enhanced suite spill collection options